The Role of an Optical Probe in Thyroid Cancer Diagnosis: Pilot Study

March 28, 2016 updated by: Stephanie Lee, Boston Medical Center

The Role of an Optical Probe in the Detection of Thyroid Cancer and Normal Thyroid Tissue in a Thyroidectomy Specimen: A Pilot Study

This study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen.

Study Overview

Status

Completed

Conditions

Detailed Description

The optical real-time readings will be compared to the histological analysis from the same area. Subjects undergoing thyroid surgery for thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules will be eligible to participate. After the removal of the thyroid gland, optical readings will be taken from the ex vivo thyroid gland and these same areas will then be analyzed in the usual standard fashion. The reading will then be correlated with the histological results. In addition, if lymph nodes are removed as part of the surgery they will also be tested prior to histological standard processing. All specimens and data will be de-identified.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tertiary hospital setting Urban hospital

Description

Inclusion Criteria:

  • Subjects undergoing thyroid surgery for thyroid nodules, thyroid cancer, and thyroid goiter with nodules.

Exclusion Criteria:

  • Subjects whose thyroid specimens have been put in formalin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules
Time Frame: two years
The objective is to assess a device called an optical probe for the differentiation of thyroid cancer from normal thyroid tissue, benign thyroid nodules or parathyroid glands, and the detection of thyroid cancer within lymph nodes using a hand-held spectroscope, compare the spectra from benign and malignant thyroid nodules and use this to discriminate benign from malignant nodules based on final histopathology or cytology as the gold standard.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Principal Investigator: Jennifer E Rosen, M.D. FACS, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H28135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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